Search results for " aggregation"
Article
Top Tips for Successful Development of Antibody Chromatography Processes
In this interview, Jakob Liderfelt, Product Manager at Cytiva, discusses main challenges faced during chromatography process development for mAbs and mAb variants such as fragments and bispecific a…
Article
Impurity Testing of Biologic Drug Products
“Historically, contamination with trace amounts of metals was a problem leading to aggregation of therapeutic proteins, which can cause significant changes in efficacy, but understanding of the phenom…
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Impact of Media Components on CQAs of Monoclonal Antibodies
…s their critical quality attributes (CQAs) including glycosylation, sialyation, charge variants, and aggregation among others (1). Optimal growth of cells requires monitoring and control of process v…
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Analyzing Proteins Using SEC, MALS, and UHPLC
Today, SEC is predominantly used to measure aggregation, because the determination of protein molecular weight by calibrating the retention times against those of known molecular standards is not effe…
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Evolution of the Monoclonal Antibody Purification Platform
The low pH elution is another potential issue as it has been linked to product aggregation.
• Low pH viral inactivation as an orthogonal step for clearance of retroviruses. This step also suff…
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Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
Studies and rankings showed that aggregation and Protein A fragmentation were crucial CQAs, Adkins said. Upstream, the most important CQAs include glucose concentration and cell mobility; downstream, …
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Fusion Proteins Pose Manufacturability Challenges
…ether can lead to instability with the composite molecule, creating manufacturing challenges such as aggregation during the cell culture or purification steps, according to Matt Kalo, associate direc…
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Virus-like Particles as Therapeutic Moieties of the Future
Physical parameters of VLPs such as molecular mass, density, size distribution, polydispersity, and conformation can be studied at high resolution, even for a heterogeneous sample without causing any …
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Moving PAT from Concept to Reality
He points to three additional microfluidics technologies—particle analyzers for on-line protein aggregation detection and monitoring, devices for on-line or at-line detection of adventitious agents, c…
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Chromatography for the Diversified Antibody Pipeline
CytivaVideo
In this video, Eva Heldin, Section Manager of Antibody Application in R&D at Cytiva is interviewed by BioPharm International and shares what antibody therapies are in the pipelin…